Objective: to evaluate the effect of aspirin(ASA) in prevention of adverse pregnancy outcomes in women with elevated level of alfa-feto protein (AFP) ,in second trimester Down syndrome screening.
Background:elevated level of AFP in second trimester screening is associated with adverse pregnancy outcome such as: pre-eclampcia or intra uterine growth restriction (IUGR).Some studies have reported antiplatelet agents prevent pre-eclampcia and its consequences. Our aim is to evaluate adverse pregnancy outcomes reduction due to aspirin effect. we evaluate the use of second trimester uterine artery doppler to predict adverse pregnancy outcome in women with elevated AFP.
Methods:this is a prospective study of women who attend for antenatal care at Imam khomeini hospital of Tehran university of medical sciences. Women with second trimester AFP > 2.5 MOM (which tested in a single reliable labratory), and 16-20 weeks gestation after giving an informed consult are enrolled in the study. Demographic questionnaire is filled. Women are divided into to groups :with or without aspirin with block randomization. Ultrasound scan for fetal anomalies and uterine arteries doppler is done for each people, but the physician is blind of patient group and screen result .Phone calls are made each months till delivery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203018954N1
Registration date:2012-06-05, 1391/03/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-05, 1391/03/16
Registrant information
Name
Sanaz Moosavi
Name of organization / entity
Imam Khomeini hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2266 3265
Email address
moosavis@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
tehran university of medical science grant
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-08-20, 1391/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Aspirin for prevention of adverse pregnancy outcome in women with elevated alfa-feto protein in second trimester screening,a randomised clinical trial
Public title
Aspirin for prevention of adverse pregnancy outcome in women with elevated alfa-feto protein
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusin criteria:16-20 gestational weeks pregnant women who attend Imam khomeini hospital clinic of perinatology,and have a second trimester AFP>2.5 MOM.They are divided into 2 groups with or without aspirin.
Patients are included in study who deliver in Imam khomeini hospital.
Exclusion criteria :maternal medical disease and uterus anomalies
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
109
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical sciences
Street address
Keshavarz blvard,tehran, iran
City
Tehran
Postal code
Approval date
2012-05-08, 1391/02/19
Ethics committee reference number
89-04-91-12005-53374
Health conditions studied
1
Description of health condition studied
Elevated level of alfa fetoprotein in second trimester screening
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Preeclampcia
Timepoint
>20 weeks gestation
Method of measurement
BP>=140/90 and 300 mg protein in 24 hour urine or ++ in a urine analysis
2
Description
Intrauterine growth restriction
Timepoint
Due to clinical condition evaluate every 4 weeks
Method of measurement
Biometry with sonography and nomograms
Secondary outcomes
1
Description
NICU admission of neonate
Timepoint
NICU admission after delivery in first 28 days of birth
Method of measurement
hospital records
2
Description
Neonatal moratlity
Timepoint
Mortality of neonate in first 28 day of birth
Method of measurement
Hospital records
3
Description
Oligohydramnios
Timepoint
>20 weeks gestation
Method of measurement
Ultrasonography
4
Description
Placenta accreta
Timepoint
In pregnancy
Method of measurement
Clinical or with ultrasonography
5
Description
Hysterectomy
Timepoint
Removal of uterus after delivery
Method of measurement
Clinical
6
Description
Relationship between increased uterine artery pulsatory index and adverse pregnancy outcome
Timepoint
Ultrasonography in 16-20 weeks gestation
Method of measurement
Doppler ultrasound of uterine arteries
Intervention groups
1
Description
aspirin usage
Category
Treatment - Drugs
2
Description
Anomaly scan ultrasonography and routine prenatal care is done
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
imam khomeini hospital
Full name of responsible person
dr sanaz moosavi
Street address
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ms Azvan
Street address
Keshvarz blvard ,Ghods Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Imam khomeini hospital
Full name of responsible person
Dr soghra khazardoost
Position
Asistant professor
Other areas of specialty/work
Street address
Imam khomeini hospital
City
Tehran
Postal code
Phone
+216 1192482
Fax
Email
drkhazardoost@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam khomeini hospital
Full name of responsible person
Dr soghra khazardoost
Position
Specialist in obstetrics and gynecology
Other areas of specialty/work
Street address
Imam khomeini hospital
City
Tehran
Postal code
Phone
+216 1192482
Fax
Email
drkhazardoost@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Sanaz moosavi
Position
Fellowship in perinatology
Other areas of specialty/work
Street address
Imam khomeini hospital , Vai-asr hospital
City
Tehran
Postal code
Phone
00
Fax
Email
moosavisanaz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)